Label: ANTIMICROBIAL HAND SANITIZER- alcohol gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51811-731-10 - Packager: Hanover Pen Corp dba HPC Global
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 30, 2020
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- Active Indgredient
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- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
ANTIMICROBIAL HAND SANITIZER
alcohol gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51811-731 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 41.405 mL in 59.15 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51811-731-10 59.15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/13/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/13/2010 Labeler - Hanover Pen Corp dba HPC Global (003022670) Registrant - Robert Houghland (003022670) Establishment Name Address ID/FEI Business Operations Hanover Pen Corp dba HPC Global 003022670 relabel(51811-731) , repack(51811-731) Establishment Name Address ID/FEI Business Operations Safetec of America Inc 874965262 manufacture(51811-731)